Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)

NCT03801941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-02

No results posted yet for this study

Summary

The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.

This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

wearing ATLAS device during evaluation at 4th day

Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.

OTHER

wearing ATLAS device during evaluation at 5th day

Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.

Sponsors & Collaborators

  • Japet Medical Devices

    collaborator INDUSTRY
  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Vincent Tiffreau, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03801941 on ClinicalTrials.gov